Vitamin D Deficiency and Placental Calcification in Low-risk Obstetric Population - Are They Related?

July 12, 2014 updated by: Ali Ozgur Ersoy, Zekai Tahir Burak Women's Health Research and Education Hospital
Maternal vitamin D deficiency has been suggested to influence fetal and neonatal health. The role of placenta in vitamin D regulation is known but alteration of Vitamin D levels at placental pathologies is unknown. Placental calcification is usually thought to be a physiological aging process. Nevertheless, it can be a pathological change resulting from the effects of environmental factors on the placenta. The aim of the investigators study was to evaluate the relationship between placental calcification and maternal and cord blood 25-hydroxyvitamin-D3 [25(OH)D] and calcium concentrations in low-risk obstetric population at term and their consequences.

Study Overview

Status

Completed

Conditions

Detailed Description

Vitamin D deficiency is a public health problem prevalent throughout the World. Low blood 25-hydroxyvitamin D3 ( 25OHD ) level was found to be associated with preeclampsia, gestational diabetes, infectious diseases, decrease in fetal bone mineralization, and increase in fetal respiratory infections and infant wheezing [1].

Requirement of vitamin D is primarily met by the exposure of skin to sun and secondarily by intake of food. The provision of vitamin D from the skin depends upon melanin pigment, the use of sun screens, age, dressing style and seasonal changes [1]. Placenta plays an important role in Vitamin D metabolism during pregnancy and some independent risk factors increasing the risk of placental dysfunction at fetomaternal interface also influence vitamin D metabolism [2,3]. Nevertheless, there can be a pathological change resulting from the effects of environmental factors on the placenta .

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Zekai Tahir Burak Maternity Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients who admitted our clinic without foreknown systemic diseases or multiple pregnancy.

Description

Inclusion Criteria:

  • Term pregnancy

Exclusion Criteria:

  • Foreknown systemic diseases, multiple pregnancy, smoking cigarettes, receiving vitamin D or calcium supplementation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1
Placental calcification of Grade 3
Group 2
No placental calcification noted, the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with low birth weight.
Time Frame: Three months
Three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of delivery with cesarean section.
Time Frame: Three months
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 21, 2014

First Submitted That Met QC Criteria

July 12, 2014

First Posted (Estimate)

July 15, 2014

Study Record Updates

Last Update Posted (Estimate)

July 15, 2014

Last Update Submitted That Met QC Criteria

July 12, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIT D PLACENTAL CALCIFICATION

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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